Requirements for outsourced activities
Article 43
1. The outsourcing of operations related to the manufacture or control of veterinary medicinal products shall be made by means of a written contract that provides for clear delineation of the responsibilities of each party. 2. The manufacturer (‘contract giver’) shall assess the suitability of the contractor (‘contract acceptor’) to carry out the outsourced activities. 3. The contract giver shall ensure that adequate information is transmitted to the contract acceptor for the performance of the outsourced activities and that the contract acceptor is aware of any problems associated with the product or the work that might pose a hazard to the premises, equipment, personnel, other materials or other products. 4. The following additional aspects shall be covered in the contract: (a) the contract acceptor shall comply with good manufacturing practice; (b) the contract acceptor shall permit audits or inspections by the contract giver and the competent authorities in connection with the outsourced activities; (c) all records related to the outsourced activities as well as the reference samples shall either be transferred to the contract giver or, in the alternative, the contract giver shall be granted access to them; (d) the contract acceptor shall not subcontract any of the work entrusted to him or her under the contract without written authorisation from the contract giver. 5. The contract giver shall review and assess the records and the results related to the outsourced activities and take relevant measures where appropriate.